• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZYNO MEDICAL, LLC ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM; LARGE VOLUME INFUSION PUMP

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZYNO MEDICAL, LLC ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM; LARGE VOLUME INFUSION PUMP Back to Search Results
Model Number Z-800WF
Device Problems Backflow (1064); Improper Flow or Infusion (2954); Infusion or Flow Problem (2964); No Flow (2991)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/11/2019
Event Type  malfunction  
Manufacturer Narrative
The actual device was tested by the service provider on (b)(6) 2019.The pump passed the flow rate testing.The reported backflow phenomenon could not be replicated.The pump met all specifications as intended.The complaint couldn't be confirmed.
 
Event Description
On 09/17/2020, a distributor of zyno medical reported a complaint.A user facility representative contacted the distributor on (b)(6) 2019, and stated that pump 502617 patient noticed "blood was coming back".The pump said it was running but no fluids were being infused.The device operator was a registered nurse.Medication being infused was saline.There was a patient involved.The patient was not harmed or injured.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM
Type of Device
LARGE VOLUME INFUSION PUMP
Manufacturer (Section D)
ZYNO MEDICAL, LLC
177 pine street
natick MA 01760
Manufacturer (Section G)
ZYNO MEDICAL, LLC
zyno medical, llc
177 pine street
natick MA 01760
Manufacturer Contact
chaoyoung lee
177 pine street
natick, MA 01760
5083158202
MDR Report Key10650044
MDR Text Key210493325
Report Number3006575795-2020-00021
Device Sequence Number1
Product Code FRN
UDI-Device Identifier00814371020037
UDI-Public00814371020037
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130690
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberZ-800WF
Device Catalogue NumberZ-800WF
Device Lot Number20161021-SH
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/17/2020
Initial Date FDA Received10/08/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/29/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-